A Pilot Study of 18F-FLT in Pediatric Patients With Central Nervous System (CNS) Tumors

NCT00633958 | Terminated Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 05-303
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

In spite of numerous advances in neuroimaging techniques, the diagnosis of pediatric brain tumors relies on the pathologic evaluation of material obtained at the time of the initial operation. While 18F-FDG-positron emission tomography (PET) helps identify higher-grade lesions due to their increased glucose metabolism, the high tracer uptake of the normal adjacent brains makes this modality of limited value. Fluorine-18 fluorothymidine (FLT) is a new imaging agent that has two significant advantages in the imaging of CNS tumors. First, this agent detects cellular proliferation directly, and second, the normal brain does not take up the agent, making a positive area(s) easy to identify. Before embarking on a large pediatric disease stratified assessment of FLT imaging in pediatric neurooncology patients, the investigators are proposing a limited patient pilot study to evaluate the biodistribution, dosimetry and specificity of this compound when compared to immunohistochemical assessment of mitotic activity in newly diagnosed patients undergoing surgical resection.

Conditions

Tumors of the Central Nervous System

Keywords

18F-FLT; FLT; PET; CNS tumors; Newly; diagnosed

Outcome Measures

Primary Outcomes (1)

• To determine the distribution, localization and kinetics of localization of 18F-FLT in pediatric patients with central nervous system tumors

  Assessed shortly after subjects undergo neuroimaging

Secondary Outcomes (1)

• To correlate the activity of administering 18F-FLT in newly diagnosed pediatric brain tumor patients to standard immunohistochemical markers of cellular activation and MRI imaging

  Assessed shortly after subjects undergo neuroimaging

Study Arms (1)

18F-FLT

EXPERIMENTAL

All subjects will receive 18F-FLT prior to PET imaging.

Drug: 18F-FLT; Radiation: PET Imaging

Interventions

18F-FLT DRUG

Patients will receive a dose of 18F-FLT through a fresh intravenous catheter as per standard PET procedures. Dosing will be based on age.

Also known as: 18F]-Fluorothymidine

18F-FLT

PET Imaging RADIATION

18F-FLT

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients with newly diagnosed central nervous system tumors undergoing planned surgical resection within 21 days.
• Patients should be \< 21 years of age at the time of diagnosis.
• Patients should be capable of achieving imaging without the need for sedation or anesthesia.
• Karnofsky Performance Status ≥ 50. For infants, the Lansky play scale ≥ 50% can be substituted.
• Patients must not be pregnant or nursing.
• Signed Informed Consent.
• Patients receiving steroids and/or anti-seizure medications are eligible for this study.

You may not qualify if:

• Prior radiation therapy and/or chemotherapy are not permitted.
• Active infection
• Pregnancy or breast feeding
• Serious concurrent medical illness

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Disease

Interventions

alovudine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Mark Kieran, MD

  Dana-Farber Cancer Institute/Children's Hospital Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 12, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

US (1)